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DISSOLUTION

Apparatus

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WHAT IS DISSOLUTION?

• the process by which a solid or liquid


forms a homogeneous mixture with a
solvent

• Tablet Dissolution is a standardised


method for measuring the rate of drug
release from a dosage form

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Goals of predictive dissolution
test

• To accessing therapeutic efficacy.


• Monitoring batch to batch consistency.
• High cost of in vitro dissolution test.
• Assessment of bioequivalence.

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FUNCTIONS OF DISSOLUTION
• Optimization of therapeutic effectiveness during
product development and stability assessment
• Routine assessment of production quality to
ensure uniformity between production lots
• Assessment of ‘bioequivalence’, that is to say,
production of the same biological availability
from discrete batches of products from one or
different manufacturers
• Prediction of ‘in-vivo’ availability, i.e.
bioavailability (where applicable)

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TYPES OF APPARATUS
• BASKET APPARATUS

• PADDLE APPARATUS

• RECIPROCATING CYLINDER

• FLOW-THROUGH CELL

• PADDLE OVER DISK

• CYLINDER

• SHAFT
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BASKET

a) Vessel :-Made up of
borosilicate glass -Semi
hemispherical bottom
-Capacity 1000ml

b) Shaft : -Stainless steel 316


-Rotates smoothly without
significance wobble

c) Basket :- Stainless steel 316


-Gold coatings up to 0.0001
inch d)Waterbath :
Maintained at 37±0.5⁰c

Use: Capsules,tablets,delayed
release,
suppositories,floating dosage
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PADDLE APPARATUS

• METALLIC, SUITABLY INERT, RIGID BLADE


AND SHAFT COMPRISING OF SINGLE
ENTITY
• SINKERS (A SMALL, LOOSE PIECE OF NON-
REACTIVE MATERIAL) MAY BE ATTACHED TO
DOSAGE UNIT TO AVOID FLOATING

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RECIPROCATING CYLINDER
1.Vessel:Cylindrical
flat bottom glass
vessel

2.Agitation type:
-Reciprocating
-Generally 5-35 rpm

3.Volume of
dissolution fluids :200-
250 ml 4.Water bath:
Maintain at 37±0.5⁰c

Use : Extended
release
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FLOW-THROUGH CELL

• 1.Reservoir:For dissolution
medium

• 2.Pump:-Forces dissolution
medium through cell -holding a
sample -Flow rate 10-100 ml/min
-Laminar flow is maintained
-peristaltic/centrifugal pumps are
not recommended

• 3.Water bath: Maintain at


37±0.5⁰c Major advantage : -to
maintain sink conditions -Large
volume dissolution media is
used.

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PADDLE OVER DISK

• 1.Vessel
• 2.Shaft:
• 3.Stirring elements
• 4.Sample holder : -Disk assembly that hold
the product in such a way that release
surface is parallel with paddle. -Paddle is
directly attached over disk assembly .
-Samples are drawn away b/w the surface of
medium and top of paddle blade.
5.Volume:900ml
• 6.Temperature:32 ⁰c

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SHAFT

• POSITIONED IN SUCH A WAY THAT ITS


AXIS IS NOT MORE THAN 2MM FROM
VERTICAL AXIS OF THE VESSEL

• SHOULD ROTATE SMOOTHLY


WITHOUT SIGNIFICANT WOBBLE

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MEDIA FOR DISSOLUTION

• POINTS TO BE REMEMBERED WHILE


SELECTING A MEDIUM

• VOLUME

• DEAERATION

• EXAMPLES OF TYPICAL MEDIA

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STANDARD VOLUMES

Paddle: 900/1000ml
Basket: 1-4 lit.
Reciprocating cylinder: 200-
250ml
Paddle over Disk: 900ml

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DEAERATION

• AIR BUBBLES CAN :


 INTERFERE WITH THE RESULT
 CAN CAUSE PARTICLES TO CLING TO
THE APPARATUS AND VESSEL WALLS
• DEAERATION CAN BE DONE BY:
 HEATING
 FILTERING
 VACUUM

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EXAMPLES OF TYPICAL MEDIA

• WATER

• PHOSHATE BUFFER, BORATE BUFER

• BUFFERS OF pH RANGE 1.2 TO 7.5

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FILTERS

• USED TO PREVENT UNDISSOLVED DRUG


PARTICLES FROM ENTERING THE
ANALYTICAL SAMPLE

• USED TO REMOVE INSOLUBLE EXCIPIENTS


WHICH MAY CAUSE TURBIDITY

• PORE SIZE MAY RANGE FROM 0.45 TO 70


µm

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SAMPLING

• MANUAL : USING PLASTIC OR GLASS


SYRINGE, A STAINLESS STEEL
CANNULA

• AUTOSAMPLING :
 BEST FOR SEVERAL TIME POINTS
 CAN BE SEMI OR FULLY AUTOMATIC

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TIME POINTS

• FOR IMMEDIATE RELEASE : 15 TO 60


MINS

• FOR EXTENDED RELEASE : AT LEAST


THREE TEST TIME POINTS ARE
SELECTED

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Dissolution test for tablets
• tablets or capsules taken orally remain one of the most
effective means of treatment available. The effectiveness of
such dosage forms relies on the drug dissolving in the fluids of
the gastrointestinal tract prior to absorption into the systemic
circulation. The rate of dissolution of the tablet or capsule is
therefore crucial.

• One of the problems facing the pharmaceutical industry is to


optimise the amount of drug available to the body, i.e. its
‘bioavailability’. Inadequacies in bioavailability can mean that
the treatment is ineffective and at worst potentially dangerous
(toxic overdose).

• Drug release in the human body can be measured ‘in-vivo’ by


measuring the plasma or urine concentrations in the subject
concerned. However, there are certain obvious impracticalities
involved in employing such techniques on a routine basis. These
difficulties have led to the introduction of official ‘in-vitro’ tests
which are now rigorouslywww.bpharmstuf.com
and comprehensively defined in the
respective Pharmacopoeia.
Dissolution test for tablets

. The principle function of the dissolution test may be


summarised as follows:

• Optimisation of therapeutic effectiveness during product


development and stability assessment.

• Routine assessment of production quality to ensure


uniformity between production lots.

• Assessment of ‘bioequivalence’, that is to say, production


of the same biological availability from discrete batches of
products from one or different manufacturers.

• Prediction of ‘in-vivo’ availability, i.e. bioavailability (where


applicable). www.bpharmstuf.com
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Dissolution test for
suppositories
•Testing for the rate of individual
release of drug substance from
suppositories has always posed a
difficult problem owing to melting
deformation dispersion in the
dissolution medium
•In early testing is carried out by a
simple placement in a beaker
containing a medium
•In an effort to control the variation in
a mass medium interface various.
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Tabular form
Name of APPARAT R p m Refer to standard Temp
the dosage US USP volume

Capsule II (Paddle) 50 Water 900 10, 20, 30,


(deaerated) 45 and 60

Capsule I (Basket) 100 Water 900 10, 20, 30,


45 and 60

Tablet II (Paddle) 50 Water 900 10, 15, 30,


45, and 60

Tablet II Paddle 50 water 900/1000 15, 20, 30

Tablet I basket 100 water 1000 10, 20, 30.

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NAME OF THE APPARATU RPM Refer to STANDARD TEMP
DOSAGE S USP VOLUME

Tablet I Paddle 50 Refer to 900 5,10,15


USP
Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 20
and 30
Capsule II (Paddle) 75 Acetate 900 1, 2, 5, 7, 9,
(Extended Buffer, pH 12 and 14
Release) 4.5 with hours
2.2%
Tween 20

Tablet II Basket Refer to 1000 10, 15


USP
Capsule I (Basket) 100 3% SLS in 900 10, 20, 30
water, pH and 45
9.6
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Factors effecting dissolution

• nature of the solvent and


solute
• temperature (and to a small
degree pressure)
• degree of undersaturation
• presence of mixing
• interfacial surface area
• presence of inhibitors (e.g., a
substance adsorbed on the
surface).
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CONCLUSION

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REFERENCE

•USP NF
•IP1996
•Industrial pharmacy BY
Lacchmann Liebermann
•www.dissolutiontech.co
m
•www.usp.org
•www.aapspharmaceutica.
com
•www.authorstream.com
•pharmtech.findpharma.co
m
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QUERIES..??

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Q U E R I E S
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